Teva Pharmaceutical Industries announced positive results from the second Phase III HALO study of fremanezumab (TEV-48125), an investigational treatment for the prevention of migraine.
In the episodic migraine (EM) study, patients treated with monthly and quarterly fremanezumab experienced clinically and statistically significant improvements in all endpoints and 12 pre-specified analyses.
Participants in this trial had a mean of 9.1 migraine days per month and reported 39 days with functional impairment per quarter. In this severely affected population, Fremanezumab given monthly improved the average number of migraine days, relative to baseline, by 41.6% for the duration of the trial (-3.7 days vs. -2.2 days for placebo, p < 0.0001).
Number of days with disability were decreased by 64.7% (p =0.0021) and medication consumption was decreased by 39.0%( p < 0.0001). The quarterly SC dose, which was uniquely tested in this program, also yielded highly significant results for decrease in migraine days (-3.4 days or 37.0%, p < 0.0001) and for all other comparisons. A
lso unique to this development, both dose regimens highly significantly improved migraine in subjects on stable doses of other prophylactic medications (-4.0 days for monthly dose vs -2.0 days for placebo, p = 0.001; -3.7 days for quarterly dose, p = 0.006).
All other pre-specified analyses were met and were highly statistically significant. The most commonly-reported adverse event in the study was injection site pain, with similar rates in the placebo and active groups.
“This is an extremely important development for Teva in our desire to make a meaningful difference to the millions of patients who suffer from migraine around the world,” said Dr. Yitzhak Peterburg, Interim President and CEO at Teva.
“Based on these data, we are confident in the potential for fremanezumab to be a differentiated treatment within the migraine marketplace, and these results are a testament to the strength of Teva’s development capabilities.”
“Teva’s HALO trials are the only Phase III anti-CGRP studies to demonstrate efficacy with both monthly and quarterly dosing for chronic and episodic patients and in patients already receiving prevention therapies. This is a major advance on existing data. The efficacy and rapid onset, as both add-on and monotherapy, quarterly dosing, and effect on disability and quality of life indicate that this therapy has the potential to set new and different benchmarks in the relief of migraine suffering," said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva.
“We are immensely proud to be able to bring to the migraine community the hope that they might soon have a new option that could provide a meaningful reduction in the migraine burden patients habitually suffer.”
With topline readout of pivotal trials for fremanezumab in both episodic and chronic migraine complete, Teva is conducting full analysis across all endpoints with plans to present more detailed findings in peer-reviewed publications and at future scientific congresses. This includes results from the pivotal trial in chronic migraine at the upcoming American Headache Society (AHS) Annual Scientific Meeting this week and results from both pivotal chronic and episodic migraine trials at the Congress of the International Headache Society (IHC) later this year.
The data in this size of population of challenging patients, and the meeting of all 25 endpoints and analyses is unmatched in this field. Based on these results, Teva plans to submit a Biologics License Application to the U.S. Food and Drug Administration (FDA) for fremanezumab later this year in both episodic and chronic migraine with anticipated approval and launch in the second half of 2018.
"The terrible impact of migraine is often not fully recognized across the world," said Marcelo Bigal, M.D., Ph.D., Chief Medical Officer and Head of Specialty Clinical Development at Teva. "Our unique development program will hopefully lead to patients having access to a new treatment option, either for use as stand-alone or as add-on therapy, as well as monthly or quarterly dosing."